- First Lipid Modifying Agent Shown to Reduce Risk of Leading
Causes of Blindness and Deteriorating Vision in Patients With Type 2
Diabetes

- Reduces Need for Laser Treatment in Patients With and Without
Known Diabetic Retinopathy

- Significantly Decreases Progression of Diabetic Eye Disease

Fenofibrate is the first and only widely available lipid modifying
agent to demonstrate significant protection to the eye of patients
with type 2 diabetes, reducing the need for laser therapy in a wide
spectrum of patients which should decrease the risk of progressive
loss of vision.

These effects appear independent from blood glucose as well as
baseline lipid levels, and are not explained by blood pressure
values.

These important, new results are published online in the Lancet
today by investigators from the Fenofibrate Intervention and Event
Lowering in Diabetes (FIELD) Study.

Analyses of the results show that fenofibrate:

- Significantly reduces the requirement for a first laser
treatment for diabetic eye disease:

- 31 per cent overall (p = 0.0002)

- 31 per cent (p = 0.002) for maculopathy, a major cause of
blindness

- 30 per cent for proliferative retinopathy (p=0.015).

- Significantly decreases the total number of laser therapies by
37 per cent (p = 0.0003).

Additionally, fenofibrate almost halved (49 per cent, p=0.0002)
the need for laser therapies in patients who were not known to have
diabetic eye disease at study entry when considering all courses of
laser therapy.

These protective effects appear to begin after only eight months
of treatment and increase throughout the five-year treatment period.

Fenofibrate also demonstrated, in a sub-study, a significant
reduction in the progression of eye disease with a:

- Several other endpoints did not differ significantly between
groups such as the occurrence of new retinopathy, of hard exudates or
worsening in visual acuity.

These new results from the FIELD trial conducted in Australia, New
Zealand and Finland, come from an analysis of the reasons for the
reduction in laser therapy reported in the initial FIELD publication
and a pre-specified ophthalmology sub-study of the effect of
fenofibrate on the progression of diabetic retinopathy in 1,012
patients who had repeated eye examinations.

Lead investigator of FIELD, Professor Anthony Keech of the NHMRC
Clinical Trials Centre, University of Sydney, Australia, said: "For
the first time we have shown that a widely available lipid modifying
agent, fenofibrate, reduces the complications of diabetic eye disease
- the major cause of impaired vision in adults in the industrialised
world."

"Importantly, the study also demonstrates that patients without
prior known diabetic eye disease (but probably already at early stage
of retinopathy) gain significantly from fenofibrate.

In this group the subsequent need for total laser therapy was
almost halved. Therefore, we can now hope that we can intervene to
significantly reduce the progression of retinopathy before it
requires laser treatment."

Importance for millions of diabetics

Eye disease, including diabetic retinopathy and macular oedema,
affects up to 50 million of the 200 million people with diabetes
worldwide, as after about 10 years of diabetes most patients will
experience clinically significant changes in their vision.

Even with intensive multifactorial therapy (antihypertensive
agents, oral antidiabetic agents, statins) retinopathy either
developed or progressed in about half of patients with type 2
diabetes within eight years (STENO 2 study).

Moreover, beyond control of blood pressure and blood glucose, no
effective treatment is widely available, according to another FIELD
investigator, Professor Paul Mitchell of Westmead Hospital, Sydney,
Australia.

He said: "We have to rely on laser treatment which is only
partially effective and can result in diminished visual field and
other adverse effects. Additionally, access to laser treatment is
limited in many countries. Therefore, these results offer an
important new treatment option to protect the eye of many patients
with type 2 diabetes."

Other clinical benefits

Additional results from the FIELD Study reported this week at the
Scientific Sessions of the American Heart Association in Orlando,
show that fenofibrate significantly decreased the risk of
non-traumatic amputations by 38 per cent (p = 0.011). Meanwhile,
earlier data demonstrated that fenofibrate also significantly reduces
microalbuminuria, a marker of the risk of progressive renal disease.

In addition to these microvascular benefits, new data presented at
the AHA 2007 demonstrate that fenofibrate reduced total CVD events by
26 per cent in diabetic patients with elevated triglycerides (>
2.26mmol/L) and low HDL-cholesterol ( < 1 mmol/L for men and < 1.3
mmol/L for women).

Discussing the implications of these new results, Professor Keech
said: "The microvascular benefits of fenofibrate - in the eye, the
limbs and the kidney - combined with the reduction in overall
cardiovascular events, means that fenofibrate offers an important
opportunity to protect patients from the most serious consequences of
type 2 diabetes.

The FIELD study and the detailed examinations in the sub-study
represent the largest randomised trial database addressing the
effects of a fibrate on diabetic retinopathy and its treatment. The
protective effects on the eye alone are enough to support its
consideration for many patients but the determination of the stage of
the disease as to when to intervene should be considered
exploratory."

Notes to editors

About the study

The Fenofibrate Intervention and Event Lowering in Diabetes
(FIELD) study was conducted in 9795 patients aged 50-75 from
Australia, New Zealand and Finland with type 2 diabetes. In addition
a sub-study was conducted in 1,012 to evaluate the development of
diabetic retinopathy and the symptoms of eye disease. The study was
supported by the manufacturer of fenofibrate, Laboratoires Fournier
SA, part of the Solvay Group: FIELD was designed, conducted and
analysed independently of the sponsor by the FIELD study
investigators, and coordinated by the NHMRC Clinical Trials Centre,
University of Sydney. Fenofibrate is marketed world-wide by Solvay
Pharmaceuticals and Abbott USA. Results of the latest study are
published on-line in the Lancet
(http://www.thelancet.com/journals/eop).

The absolute risk reductions in first laser treatment were:

- Overall 1.5 per cent

- Maculopathy 1.0 per cent

- Proliferative retinopathy 0.7 per cent.

About diabetic eye disease

Diabetes-related eye disease is common and if untreated or poorly
treated leads to deterioration of vision and ultimately blindness. It
occurs when the small vessels (microvasculature) of the eye are
damaged by the consequences of diabetes such as increased glucose and
raised blood pressure. Research also suggests other critically
important factors such as inflammation of the small vessels of the
eye which significantly increase the risk of damage to the retina.

What are diabetic retinopathy and macular oedema?

Diabetic retinopathy arises from changes in the blood vessels of
the retina, a nerve layer behind the eye that senses light. When
these blood vessels become damaged, vision loss occurs by two
processes known as "proliferative retinopathy" and "macular oedema".
Proliferative retinopathy occurs when new vessels bleed into the
centre of the eye often resulting in blurred vision. Macular oedema
occurs when fluid leaks from these blood vessels into the centre of
the retina or macula, making it difficult to focus. Both of these
conditions may eventually destroy the retina if left untreated. While
laser therapy is a successful treatment in preventing blindness, it
may result in the loss of vision when the macula is already involved.